PMA P160055S055

Device: RxSight Light Adjustable Lens; Light Delivery Device
Applicant: Rxsight, Inc.
PMA number: P160055
Supplement: S055
Product code: PZK
Decision date: 2026-06-08
Classification: Ophthalmic
Generic name: Light adjustable lens (LAL) and light delivery device (LDD)
Approval order statement: approval for a change in the routine Ethylene Oxide sterilization process parameters, specifically a reduction in the Ethylene Oxide gas concentration used to terminally sterilize the subject devices

Current openFDA PMA Record#

Device: RxSight Light Adjustable Lens; Light Delivery Device
Applicant: Rxsight, Inc.
PMA number: P160055
Supplement: S055
Product code: PZK
Generic name: Light adjustable lens (LAL) and light delivery device (LDD)
Decision date: 2026-06-08
Decision code: APPR
Date received: 2026-04-17
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: approval for a change in the routine Ethylene Oxide sterilization process parameters, specifically a reduction in the Ethylene Oxide gas concentration used to terminally sterilize the subject devices